
Polymedco, Inc.
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NYCOCARD U-ALBUMIN AND U-ALBUMIN CONTROL is an FDA 510(k)-cleared medical device (K053553) manufactured by Polymedco, Inc.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 8, 2006. Regulation: 8.